Merck & Co Inc. (MRK), known as MSD outside of the U.S. and Canada, announced Friday positive topline results from the Phase 3 KEYNOTE-A39 trial, which was conducted in collaboration with Seagen Inc. (SGEN) and Astellas Pharma Inc. (ALPMY.PK,ALPMY).
The trial evaluated KEYTRUDA, Merck's anti-PD-1 therapy, in combination with Padcev versus chemotherapy in patients with previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC).
In the trial, KEYTRUDA in combination with enfortumab vedotin met its dual primary endpoints of overall survival (OS) and progression-free survival (PFS), demonstrating a statistically significant and clinically meaningful improvement versus chemotherapy in patients with previously untreated la/mUC.
The trial enrolled patients who may or may not be eligible for treatment with cisplatin-based chemotherapy, regardless of PD-L1 status.
The combination also showed a statistically significant improvement in overall response rate (ORR), a key secondary endpoint, versus chemotherapy. The safety profile of KEYTRUDA and enfortumab vedotin in this study was consistent with previously reported studies of this combination.
The Phase 3 KEYNOTE-A39 trial is intended to serve as the confirmatory trial for the current U.S. accelerated approval of KEYTRUDA in combination with enfortumab vedotin.
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